FDA 510(k)

Promogran Prisma™ Collagen Matrix with ORC and Silver

Номер K: K251999 · 2026-03-13

Дата решения2026-03-13

Код продуктаFRO

РешениеSubstantially Equivalent

Описание устройства

Promogran Prisma™ Collagen Matrix with ORC and Silver is the device name listed in this FDA 510(k) record. The listed applicant is Solventum Germany GmbH. It received FDA 510(k) clearance on 2026-03-13 under 510(k) number K251999. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Promogran Prisma™ Collagen Matrix with ORC and Silver?

Promogran Prisma™ Collagen Matrix with ORC and Silver is a medical device that received FDA 510(k) clearance on 2026-03-13. The listed applicant is Solventum Germany GmbH. The 510(k) number is K251999.

When did Promogran Prisma™ Collagen Matrix with ORC and Silver receive FDA 510(k) clearance?

Promogran Prisma™ Collagen Matrix with ORC and Silver received FDA 510(k) clearance on 2026-03-13, under 510(k) number K251999.

Who is the listed applicant for Promogran Prisma™ Collagen Matrix with ORC and Silver?

The FDA 510(k) record lists Solventum Germany GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Promogran Prisma™ Collagen Matrix with ORC and Silver?

The FDA product code for Promogran Prisma™ Collagen Matrix with ORC and Silver is FRO. This falls under the Anesthesiology category.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Связанные устройства (Код: FRO)

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbH K254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLC K261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLC K251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Официальный источник

Посмотреть в базе данных FDA →

Данные получены из открытого API FDA. Для получения наиболее актуальной и авторитетной информации всегда обращайтесь к официальным записям.